Potassium-Free Urinary Alkalizing Tablet for IC/BPS
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Solution Overview
Problem
Current treatments for interstitial cystitis/bladder pain syndrome (IC/BPS) lack a long-lasting, potassium-free urinary alkalizing solution that can maintain a stable urine pH between 6.9 and 7.5 for an extended period, as existing products either contain potassium, which worsens symptoms, or have short-lasting effects due to rapid pH fluctuations.
Innovation Solution
A potassium-free, sustained and controlled-release tablet composition comprising citric acid, sodium citrate, and magnesium citrate, formulated with excipients like Aerosil, Avicel DG, and Benecel HPMC to provide a constant therapeutic alkalizing concentration for 12 hours, avoiding liquefaction and optimizing rheological features for prolonged urine pH management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Temperature
If existing urinary alkalizing products are used, then urine pH can be increased, but they contain potassium which worsens IC/BPS symptoms
Solution Approach 1:
The invention extracts and removes potassium from the alkalizing composition while retaining other effective alkalizing agents (sodium citrate, magnesium citrate, calcium citrate). This selective extraction eliminates the harmful potassium irritation to IC/BPS patients while preserving the urine alkalizing effect that raises pH to the therapeutic range of 6.5-7.5
Solution Approach 2:
The invention modifies the chemical composition quality by substituting potassium citrate with alternative citrate salts (sodium, magnesium, calcium) that provide equivalent alkalizing effects without the harmful potassium content. This local compositional change maintains the desired urine pH elevation while eliminating the specific harmful factor of potassium irritation
2Temperature
If conventional alkalizing tablets are administered, then urine pH increases temporarily, but the effect lasts only 2-4 hours due to rapid pH fluctuations
Solution Approach 1:
The invention incorporates pH buffer systems and sustained-release excipients in advance within the tablet formulation. These pre-integrated components gradually release the alkalizing agents over an extended period of 12-24 hours, preventing rapid pH fluctuations and maintaining stable therapeutic pH levels throughout the dosing interval
Solution Approach 2:
The invention changes the release kinetics parameter of the alkalizing agents by using sustained-release matrix formulations. This transforms the rapid release profile (2-4 hours) into a controlled, prolonged release profile (12-24 hours), thereby extending the duration of therapeutic effect and stabilizing urine pH over time
3Temperature
If multiple tablets are taken daily to maintain pH, then alkalizing effect is improved, but treatment complexity and dosage frequency increase
Solution Approach 1:
The invention merges multiple dosing events into a single extended-release tablet that provides sustained alkalizing effect throughout the day. By combining sufficient quantities of alkalizing agents and sustained-release excipients into one tablet, it replaces the need for multiple daily doses with a single convenient administration that maintains stable urine pH for 12-24 hours
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The tablet achieves a sustained release of active ingredients, maintaining urine pH within the optimal range for 12 hours, reducing symptom flare-ups and minimizing potassium irritation, thus providing a more effective and safer treatment option for IC/BPS.
Implementation Method 1
a sustained and/or controlled release dosage form
Implementation Method 2
a sustained and/or controlled release dosage form
Implementation Method 3
by alkalizing the urine and/or for general alkalization of the human body
Data Source
AI summary
The present invention relates to novel medicinal and/or pharmaceutical urinary, extended-release alkalizing composition advantageously a tablet for the oral treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) and/or for general alkalization of the human body for long term where according to the subject matter of the invention the composition is potassium free, the composition has a sustained and/or controlled release dosage form and comprises following components advantageously with certain consistence: Citric acid, Sodium citrate, Magnesium citrate, and comprises following components advantageously with a certain consistence as excipients: Aerosil, Avicel DG, Benecel hypromellose microcrystalline cellulose (HPMC) as grade, advantageously Benecel K100M PH DC HPMC and Magnesium stearate. The subject matter of the present invention relates furthermore to novel medicinal and/or pharmaceutical urinary, extended-release alkalizing composition wherein a single administered dose of the composition achieves a therapeutic alkalizing concentration for providing a neutral pH value of the urine between values of 6.9 to 7.5 advantageously 7.38 in an individual for 12 hours. According to the release kinetics of the active ingredient of the composition the final conclusion is that the sustained and/or controlled release tablet according to the invention provides in vivo constant and continuous therapeutic concentration in case of 2×1 daily dosage. The subject matter of the present invention furthermore relates to the process for the formulation of the composition according to the invention because during the homogenization of the above described active ingredients a special formulation process is needed for avoiding liquefaction and the formation of eutectic.